RecruitingPhase 3NCT06934655

Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth

Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth: A Randomized Clinical Trial


Sponsor

Children's Hospital Los Angeles

Enrollment

150 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Semaglutide 2.4 mg for people with metabolic and bariatric surgery, pediatric obesity, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSemaglutide 2.4 mg

The dosing regimen will follow standard titration protocols, starting with a dose of 0.25 mg weekly for the first month, with gradual increases in dosage each month to a target dose of 2.4 mg weekly by the fifth month. To minimize the potential for side effects impacting daily activities, youth in the semaglutide group will be instructed to administer the medication weekly on Fridays.


Locations(1)

Children's Hospital Los Angeles

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06934655


Related Trials